Data Integrity Key for GMP Compliance Workshop
26 May 2016
The first workshop of our "Data Integrity Key for GMP Compliance" working group, founded in 2016 within the ISPE Turkey Affiliate, will be held in May 26, 2016 at Gebze 1 facility of Sandoz.
General titles referred at Data Integrity Industry Gathering that was held on March 21, 2016 at The Grand Tarabya, will be discussed in details; several FDA warning letters will be reviewed and delegates from Sandoz will elaborate on data integrity studies conducted on the site.
We wish to be together at our workshop where Data Integrity topics will be evaluated on a sectoral basis.
The first workshop of our "Quality & Metrics working group, founded within the ISPE Turkey Affiliate in 2016 and leaded by İlknur Gümüşeli Hırçın, was held in May 4, 2016 at Topkapı facility of Bayer Turkey.
Following the General Assembly of ISPE Turkey Affiliate, the workshop was initiated with opening remarks of our Chair Fatma Taman and Board Member İlknur Gümüşeli Hırçın. Discussions around "Quality Metrics" concept, practices and challenges in this regard were covered via the detailed Requirements and Assessment of Quality Metrics presentation of our Board Member Havva Çınar Aşar.
We hope to be together in workshops and seminars that will be planned as sequels of our interactive workshop where sectoral discussions and assessments were made on "Quality Metrics" studies.
ISPE Turkey Affiliate's Spring Seminar on Good Distribution Practices for APIs, Pharmaceuticals and Biopharmaceuticals" was held on 15 April 2016, at Barbaros Point Hotel, Istanbul.
The seminar which brought together participants from various areas such as pharmaceutical industry, suppliers, and academy, opening remarks of our Chair Fatma Taman were followed by ISPE's Vice President for European Operations Dr. Thomas Zimmers presentation on the ongoing studies for ensuring the continuity of drug supply.
GDP implementations for pharmaceutical and biological products were explained by Khalid Alfhaid, International Quality Senior Manager from Amgen and real-life examples on GDPs were presented by Zafer Öztuncer, Intercontinental Quality Assurance Director from Merck Pharmaceuticals.
On the afternoon session of the seminar, Jean-Marie Higel, Head of Service Quality in Global Services at BASF presented Good Distribution Practices for APIs and Deva Holding Logistics Manager Gürcan Coşgun elaborated on the transportation requirements in the scope of GDP. The seminar was concluded with an interactive panel session where GDP topics were discussed at a wide range with the contributions of the speakers and participants.
Our Affiliate Chair Ms. Fatma Taman made a presentation with the title of "ISPE Turkeys Perspective on Evolving Regulations and Facilities of the Future on Thursday, April 21, 2016 at Cleanroom Technology, Maintenance and Equipment Exhibition organized on 21-23 April 2016 in ICEC Lütfi Kırdar International Congress and Exhibition Center, İstanbul.
Following a quick overview of ISPE Turkey Affiliates recent accomplishments, hot topics that will soon impact the pharmaceutical industry both on a national and international level such as Industry 4.0, GMP revisions, future-proof facilities were covered and were followed with great interest by the representatives of health, medicine and chemical sectors as well as pharmaceutical and biotechnology industry experts.
The visitors were informed about the objectives, training programs, working groups and global events of ISPE Turkey Affiliate via the booth that was set up at the exhibition which gathered cleanroom specialists and managers, laboratory assistants, facilities and process managers, maintenance engineers, quality control experts and R&D managers.
For more information about the exhibition: http://www.expocleanroom.com/default.asp
Quality & Metrics Workshop
May 4, 2016
The first workshop of our "Quality & Metrics working group, founded in 2016 within the ISPE Turkey Affiliate, will be held in May 4, 2016 at Topkapı facility of Bayer Türk.
The workshop will begin following the General Assembly of ISPE Turkey Affiliate and will cover discussions around "Quality Metrics" concept, practices and challenges in this regard.
We wish to be together at our workshop where studies on "Quality Metrics" will be assessed and evaluated on a sectoral basis.
Good Distribution Practices for APIs,
Pharmaceuticals and Biopharmaceuticals
15 April 2016
ISPE Turkey Affiliate's Spring Seminar on Good Distribution Practices for APIs, Pharmaceuticals and Biopharmaceuticals" will be held on 15 April 2016, at Barbaros Point Hotel, Istanbul.
Studies for ensuring the continuity of drug supply will be presented by ISPE's Vice President for European Operations Dr. Thomas Zimmer, GDP applications for pharmaceutical and biological products will be explained by International Quality Senior Manager Khalid Alfhaid from Amgen Inc. and Intercontinental Quality Assurance Director Zafer Öztuncer from Merck Pharmaceuticals will relay information about cold chain practices for pharmaceutical and biopharmaceutical products. Following the presentation on GDP practices for APIs by Jean-Marie Higel, Head of Service Quality in Global Services at BASF; Deva Holding Logistics Manager Gürcan Coşgun will elaborate on the transportation requirements in the scope of GDP.
We look forward to your attendance to this important seminar which will cover the regulations about the storage and distribution practices for active ingredients, pharmaceuticals and biopharmaceuticals.
Participation Fee: For Members: 900 TL, For Non-Members: 1500 TL
Deadline for registration: 8 April 2016
Fatma Taman, Chair of ISPE Turkey Affiliate, and Buket Hekiman Bayraktar, General Secretary of ISPE Turkey Affiliate, met with future pharmacists in Career Days event of Istanbul Kemerburgaz University. During the visit on March 30th 2016, they contributed to shape future careers of pharmacist candidates by providing information about the working areas of pharmacists through the presentation titled as "Pharmacists in the Pharmaceutical Industry". Students were also guided to access current information for the pharmaceutical industry via ISPEs knowledge resources.
ISPEs Continuous Manufacturing Conference will take place on 20 21 April in Baltimore, Maryland USA. The conference will focus exclusively on Continuous Manufacturing an increasingly popular production strategy with numerous benefits, but also many challenges.
ISPE Turkeys industry gathering around the topic of Data Integrity that was held at The Grand Tarabya on 21 March 2016 was initiated by an introduction of industry gathering series by the Affiliates Chair Fatma Taman. The meeting turned out to be a very interactive one with everyones contributions, following the presentations of Figen Ergin (BTS Information Services) and Timur Kabadayı (Conval Group). The group decided to take the collaborative work further at future workshop platforms.
Industry Gatherings: Data Integrity
21 March 2016
As of 2016, ISPE Turkey Affiliate wish to gather the representatives of our sector in the afternoon meetings that will be organized around the current issues important for our industry.
The first one of our activities in the scope of those Industry Gatherings will be held on March 21, 2016 and will cover the topic of "Data Integrity" which currently has an increasing effect for all of us.
Date: March 21, 2016 - Monday
Time: 17:30 - 19:30
Location: The Grand Tarabya - Rumeli & Hisar Hall
Detailed information regarding the accomplishments and future goals of ISPE Turkey Affiliate can be found in the 10th anniversary video. Click here to see the video.
On the occasion of 10th Anniversary of ISPE Turkey Affiliate, our Chair Fatma Taman attended the live broadcast of Bloomberg HT news bulletin on February 24, 2016. The broadcast can be seen from here.
The news about our seminar "A Holistic Look at Pharmaceutical Industry on the 10th Anniversary of ISPE Turkey" and 10th Anniversary Celebration that were organized on the 3th of December, 2015 at Four Seasons Hotel, Istanbul-Sultanahmet with the attandance of delegates from the pharmaceutical industry, suppliers, academy and Turkish Medicines and Medical Devices Agency officials was published in the January-February 2016 issue of OTC News magazine.
Once again we thank all of our participants who were together with us on this important day and we would like to express our wish to carry on our tradition of conducting groundbreaking projects with which we leave our mark on the future, in the next decades with the contributions of all our stakeholders.
The 2016 ISPE Europe Annual Conference Integrated Technology, Quality and Compliance Strategy for Effective Operations will bring together pharmaceutical, regulatory and technology experts from around the world in Frankfurt in 7-9 March 2016.
The conference will be initiated with executive speeches around the topics of operational excellence, continuous manufacturing and new regulations for pharmaceuticals and biopharmaceuticals and will continue with paralel tracks including GMP updates, facilities of the future, data integrity, risk management and innovative approaches for technical matters.
This two-and-a-half-day, must-attend, education conference will use best practice case studies to explore current technologies, regulatory requirements and will provide delegates with techniques for the evaluation and implementation of cutting-edge technologies. The Conference is aimed at Pharma Development Experts, Quality Management, Quality Assurance, Quality Operations, Quality Control, Quality Systems, Production & Distribution Personnel, Professionals Involved in Manufacturing, Development and Technology Transfer as well as Suppliers and Regulators with interest in new solutions and experiences.
Details about the conference and registration form can be found in the following link: www.ISPE.org/2016-Europe-Annual-Conference
Through the Tulak Tacloban project that ISPE Philippines had supported and ISPE Turkey Affiliate had also contributed after the Typhoon Haiyan hit the Philippines in 2013, 130 schoolchildren finished primary/elementary schooling at mobile schools and these same children are now volunteers in their own community for calamity awareness.
Seminar and 10th Anniversary Celebration / 03 December 2015
ISPE Turkey Affiliates seminar around the theme of A Holistic Look at Pharmaceutical Industry on the 10th Anniversary of ISPE Turkey" and the cocktail was held on December 3, 2015 at Four Seasons Hotel Sultanahmet, İstanbul with the participation of delegates from the pharmaceutical industry, suppliers, academy and Turkish Medicines and Medical Devices Agency officials.
The presentations about Harmonization in GMPs, EU and PIC/S GMP Recent Changes were made by Dr. Vee Revithi, Turkish Medicines and Medical Devices Agency PIC/S Processes by Pharm. Gülşen Yılmaz, Management of Generation Conflicts by Dr. Buket Aksu. Fatma Taman/ Chair of ISPE Turkey Affiliate, Dr. Ünsal Hekiman/ Founder and Honorary Chairman of ISPE Turkey Affiliate, Prof. Dr. Ahmet Araman/ Past Chair of Turkey Affiliate and Dr. Theodora Kourti/ ISPE Senior Vice President for Regulatory Affairs held a speech about the ISPEs activities with regards to the 10th Anniversary of the Affiliate.
While the Affiliates achievements for the past 10 years and the targets for the future were presented through the introductory video; it was also announced that grants to support education set in the name of late Board Member Zehra Gürol will be spread out with the contributions of the Affiliates gold sponspors.
Following the presentation of plaques to our event sponsor BTS and Founder Board Members, our 10th Anniversary was celebrated by cutting the 10th year cake all together and enjoying the cocktail reception with live classical music with the participation of all our guests.
We wish to carry on our tradition of conducting groundbreaking projects with which we leave our mark on the future, in the next decades with the contributions of all our stakeholders...
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